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Vertebral column / Food law / Neurosurgery / Orthopedic surgery / Vertebral fixation / Medical device / Premarket approval / Spondylolisthesis / Scoliosis / Medicine / Health / Food and Drug Administration


APR a[removed]K13[removed]k) Sumnmary Pursuant to 2l CFR[removed]Sponsor:
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Document Date: 2013-05-06 11:18:47

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File Size: 152,64 KB

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Company

K130286 Trade / Synthes / Pioneer Surgical Technology Inc. / 2 PO ER Vl RNE1ECAR Trade / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

cleared pedicle screw systems / announcements concerning your device / predicate devices / predicate device / Internet address http /

MedicalCondition

deformities / spinal stenosis / tumor / degenerative disc disease / kyphosis / spondylolisthesis / i.e. scoliosis / discogenic back pain / lordosis / /

MedicalTreatment

spinal surgery / /

Organization

Division of Postmarket Surveillance / Orthopedic Devices office of Device Evaluation / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Division of Orthopedic Devices / HUMAN SERVICES Public Health Service Food and Drmg Administration / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Mark N. Melkerson Director Division / CDRH's office of Surveillance / Center for Devices and Radiological Health Enclosure / /

Person

Silver Spring / Ronald P.Jean / Emily Downs / Mark N. Melkerson / /

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Position

surgeon / /

Product

K130286 Indications / Federal Food / /

ProvinceOrState

Maryland / Michigan / /

Technology

radiation / fundamental scientific technology / /

URL

http /

SocialTag